This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.

Other Name: ST Monitoring Feature

Detailed Description:

This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Willing and able to comply with protocol requirements, including keeping all required visits

Willing to participate in the study and able to sign an IRB approved informed consent form

Be at least 18 years of age when enrolled in the study

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)

Have NYHA Class IV Heart Failure

Have persistent or permanent atrial fibrillation

Have a known history of intermittent Bundle Branch Block

Pregnant or planning a pregnancy during the study participation

Have a life expectancy of < 1 year due to any condition

Are currently participating in a clinical investigation that includes an active treatment arm.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424722